Condition category
Digestive System
Date applied
14/06/2015
Date assigned
30/06/2015
Last edited
17/08/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Stroke is the second leading cause of death and disability among adults worldwide and the prevalence is still increasing. Constipation is one of the most common complications after stroke that severely influences patients’ quality of life and their rehabilitation. Studies indicate that about 30% to 60% of stroke patients have suffered from constipation after stroke. Although treatments for constipation are varied, many of them are difficult to tolerate or are rejected because of adverse events, or have not been proven to be effective. Acupuncture may be effective for constipation but studies focusing on acupuncture for constipation after stroke are rare. The aim of this study is to compare the effectiveness of acupuncture, mosapride citrate tablet and routine health care in patients with constipation after ischemic stroke.

Who can participate?
Patients aged between 30 and 75 diagnosed with ischemic stroke with symptoms of constipation.

What does the study involve?
Participants will be randomly allocated into one of three groups. The first group will be treated with acupuncture. They will receive 16 treatment sessions over 4 weeks. Each session will last for 30 minutes. The second group will take a mosapride citrate tablet three times a day for 4 weeks. The third group will receive routine treatment and healthcare for ischemic stroke.

What are the possible benefits and risks of participating?
The participants' symptoms of constipation may be improved by participating in the study. The results of the study will help clinicians select more effective treatments for constipation. Participants may feel soreness, numbness, distension or heaviness around the acupuncture points. If the following events occur, they will be regarded as adverse events and the researchers will treat the participants with relevant conventional therapy, or even hospitalize them. The adverse events include local hematoma (a solid swelling of clotted blood), breaking of needle, retained needle after treatment, fainting, unbearable prickling, severe pain or discomfort persisting more than 1 hour after acupuncture, local infection and abscess, diarrhea, abdominal pain, and hives.

Where is the study run from?
Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University (China).

When is the study starting and how long is it expected to run for?
From December 2015 to July 2018.

Who is funding the study?
Beijing Municipal Science and Technology Commission, Beijing Municipal Administration of Hospitals, Ministry of Science and Technology of the People's Republic of China and State Administration of Traditional Chinese Medicine of the People's Republic of China.

Who is the main contact?
Dr Tao Zhang

Trial website

Contact information

Type

Scientific

Primary contact

Dr Tao Zhang

ORCID ID

http://orcid.org/0000-0002-8349-9091

Contact details

Beijing Hospital of Traditional Chinese Medicine
No. 23 Meishuguanhoujie
Dongcheng District
Beijing
100010
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The effect of acupuncture versus mosapride citrate tablet versus routine health care in improving spontaneous bowel movements, stool consistency and straining during defecation in patients with constipation after ischemic stroke: a single-centre randomised controlled trial

Acronym

Study hypothesis

Acupuncture is effective for constipation after ischemic stroke. The effect of acupuncture is at least equivalent to mosapride citrate table but is better than conventional health care.

Ethics approval

Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, 09/07/2015, ref: 2015BL-041-01

Study design

Single-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Constipation after ischemic stroke

Intervention

1. Acupuncture group: acupuncture point selection: CV13 (Shangwan), CV12 (Zhongwan), CV10 (Xiawan), bilateral ST25 (Tianshu), CV6 (Qihai), bilateral PC6 (Neiguan) and bilateral ST36 (Zusanli). Each session will last for 30 minutes. Every participant will be treated once a day and will receive 16 treatment sessions in total during 4 continuous weeks. Treatment will be conducted 5 times per week in the first 2 weeks and 3 times per week in the last 2 weeks.
2. Medicine group: mosapride citrate tablet will be taken orally at the dose of 5 mg, three times a day for 4 weeks continuously.
3. Control group: participants of control group only receive routine treatment and healthcare for ischemic stroke. For participants who have had no bowel movements over 4 or more consecutive days, a cathartic will be used as an emergency drug.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

The change of mean weekly complete spontaneous bowel movements (CSBMs) from baseline; measured at the 4th and the 8th week after randomisation

Secondary outcome measures

1. The change of mean weekly spontaneous bowel movements (SBMs) from baseline, measured at the 4th and the 8th week after randomisation
2. The change of mean scores of stool consistency from baseline, measured at the 4th and the 8th week after randomisation
3. The change of mean scores of straining during defecation from baseline, measured at the 4th and the 8th week after randomisation
4. The change of weekly frequency of using laxatives from baseline, measured at the 4th and the 8th week after randomisation

Overall trial start date

01/12/2015

Overall trial end date

31/07/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosed with ischemic stroke according to the diagnostic criteria specified by the World Health Organization (WHO)
2. With symptoms of constipation according to the Rome III functional constipation criteria
3. 2 weeks to 6 months after stroke onset
4. Aged between 30 and 75 years old, either gender
5. The Glasgow Coma Scale (GCS) score ≥ 7 and the National Institute of Health Stroke Scale (NIHSS) ≤ 21, which indicates that participants are conscious and without dysfunctions in comprehension
6. With no previous medical history of constipation before stroke onset and the symptoms of constipation present at least 2 weeks continuously after stroke
7. No use of gastrointestinal drugs 1 week before randomisation (except for emergency drugs)
8. No acupuncture treatment for constipation in the previous 2 weeks
9. Volunteered to join the clinical trial and provided a signed informed consent form

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120 participants in total and 40 participants in every group.

Participant exclusion criteria

1. Irritable bowel syndrome (IBS) and constipation secondary to organic diseases (for example, endocrine, metabolic or postoperative diseases) or drugs
2. Participants with abdominal aneurysm, hepatosplenomegaly, serious cardiovascular, liver, kidney or psychiatric disease, or severe dystrophy who cannot cooperate to be examined or treated
3. Pregnant women or women in lactation
4. Blood coagulation disorders, or administration of anticoagulant agents such as warfarin and heparin (participants treated with antiplatelet treatment such as asprin or clopidogrel as secondary prevention of cerebral infarction are eligible)

Recruitment start date

01/12/2015

Recruitment end date

28/02/2018

Locations

Countries of recruitment

China

Trial participating centre

Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University
No.23 Meishuguanhoujie Dongcheng District
Beijing
100010
China

Sponsor information

Organisation

Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University

Sponsor details

No. 23 Meishuguanhoujie
Beijing
100010
China

Sponsor type

Hospital/treatment centre

Website

http://www.bjzhongyi.com/

Funders

Funder type

Government

Funder name

Beijing Municipal Science and Technology Commission

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Beijing Municipal Administration of Hospitals

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Ministry of Science and Technology of the People's Republic of China

Alternative name(s)

Chinese Ministry of Science and Technology, MOST

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

China

Funder name

State Administration of Traditional Chinese Medicine of the People's Republic of China

Alternative name(s)

State Administration of Traditional Chinese Medicine, State Administration of TCM, SATCM

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

China

Results and Publications

Publication and dissemination plan

The result of this study will be disseminated via peer-reviewed publications and conference presentations.

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes